Methocarbamol + Opioids for Hernia Pain Management

Overseen By Jeremy A Warren, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Prisma Health-Upstate

Must not be taking: Opioids

Disqualifiers: Pregnancy, Chronic opioid users, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of methocarbamol, a muscle relaxant, for pain relief after hernia surgery compared to standard opioids. Researchers will examine three treatment groups: methocarbamol alone, standard opioids alone, and a combination of both. It suits individuals who have recently undergone ventral or inguinal hernia surgery and are not chronic opioid users. Participants will engage in the study for about 30 days post-surgery, contributing to identifying the best pain management strategies for these common procedures. As a Phase 4 trial, this research focuses on an FDA-approved treatment to understand its benefits for a broader patient population, offering participants a chance to improve post-surgery pain management.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, chronic opioid users are excluded from participating, which suggests that ongoing opioid use might not be allowed.

What is the safety track record for methocarbamol and standard opioid treatments?

Research has shown that methocarbamol is generally safe. This muscle relaxant helps reduce pain after surgery. However, when combined with opioids, it can increase drowsiness, so careful monitoring is advised.

Opioids are often used to manage post-surgical pain. They are effective but can cause side effects like drowsiness and, with prolonged use, addiction. Weighing the benefits and risks of opioid use is important.

In summary, both methocarbamol and opioids have specific safety considerations. Methocarbamol is safe but requires caution when used with opioids. Opioids are effective but may cause side effects if misused. Participants should consider these factors when deciding to join the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using methocarbamol alongside standard opioids for hernia pain management because it offers a unique approach to pain relief. Methocarbamol is a muscle relaxant that works differently from opioids, which primarily target pain receptors in the brain. By adding methocarbamol, the treatment could potentially reduce the amount of opioids needed, minimizing the risk of dependency and side effects associated with opioid use. This combination might provide more comprehensive pain management for patients undergoing hernia repair, addressing both muscle-related discomfort and severe pain more effectively.

What evidence suggests that this trial's treatments could be effective for hernia pain management?

Research has shown that methocarbamol can reduce pain after surgery. In earlier studies, patients who took methocarbamol reported significantly less pain than those who did not. Methocarbamol also reduces the need for opioids, which are strong painkillers that can cause side effects. In this trial, some participants will receive both methocarbamol and opioids, potentially achieving better pain management with smaller opioid doses. Thus, methocarbamol may control pain while decreasing opioid use. ^{4 6 7 8 9}

Who Is on the Research Team?

Jeremy Warren, MD

Principal Investigator

Prisma Health

Are You a Good Fit for This Trial?

Adults over 18 undergoing ventral or inguinal hernia repair who consent to randomization can join this trial. It's not for those under 18, pregnant individuals, or chronic opioid users.

Inclusion Criteria

I am older than 18 years.

I am having an open incisional hernia repair.

Patients who have given consent for randomization

Exclusion Criteria

Chronic opioid users

Pregnancy

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive methocarbamol, standard opioid, or a combination after hernia repair surgery

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Methocarbamol
• Standard Opioid

Trial Overview

The study is testing methocarbamol as a pain treatment after hernia surgery. Participants will either receive standard opioids alone, methocarbamol alone, or both together in different groups based on the type of surgery they have.

How Is the Trial Designed?

Group I: primary ventral hernia repair or inguinal hernia repair Experimental Treatment 2 Interventions

Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias. Primary or recurrent inguinal hernias.

Group II: open or robotic ventral hernia repair outpatient Experimental Treatment 2 Interventions

Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.

Group III: open or robotic hernia repair inpatient Experimental Treatment 2 Interventions

Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.

Methocarbamol is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Robaxin for:

• Muscle spasms
• Pain management

Approved in Canada as Methocarbamol for:

• Muscle spasms
• Pain management

Approved in European Union as Robaxin for:

• Muscle spasms
• Pain management

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

Published Research Related to This Trial

In a study evaluating 13 analgesic drugs for postoperative pain relief, levorphanol 2 mg was found to be significantly more effective than the standard reference drug pethidine 100 mg.

Oxycodone 10 mg, pentazocine 20 mg, and a combination of morphine 10 mg with cyclizine 50 mg also showed strong efficacy, but no drug combinations outperformed the individual analgesics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled comparison of the efficacy of fourteen preparations in the relief of postoperative pain. Morrison, JD., Loan, WB., Dundee, JW.[2019]

Opioids can be effective and relatively safe options for managing pain, but they are often avoided due to concerns about potential side effects and adverse events.

The side effects of opioids can affect multiple body systems, but with proper management and quick intervention, these effects can be addressed, allowing opioids to be used safely and effectively for pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. Herndon, CM., Kalauokalani, DA., Cunningham, AJ., et al.[2019]

In patients with renal impairment, safer analgesic options include alfentanil, buprenorphine, and fentanyl, as they do not produce high levels of active metabolites or have prolonged clearance, making them suitable for managing acute pain.

For patients with hepatic impairment, remifentanil is the least affected by altered drug clearance, but caution is needed with other analgesics, as many require close monitoring and some, like methadone, are contraindicated in severe liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. Murphy, EJ.[2019]

In a study of patients undergoing primary ventral and inguinal hernia repairs, the addition of methocarbamol significantly reduced opioid prescriptions and total morphine milligram equivalents (MME) without increasing the need for additional pain relief medications.

Patients receiving methocarbamol had a lower percentage of opioid prescriptions (55.8% for PVHR and 67.3% for IHR) and lower MME (20 for PVHR and 25 for IHR), indicating that methocarbamol can effectively manage pain while minimizing opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of methocarbamol on opioid use after primary ventral and inguinal hernia repair. Crosier, C., Hammond, B., Carbonell, C., et al.[2023]

A multimodal approach to managing acute postoperative pain, which includes various medications like alpha 2 agonists, gabapentinoids, and dexamethasone, can enhance pain relief while potentially reducing opioid use and associated side effects.

Alpha 2 agonists can provide opioid-sparing effects but may cause hypotension and bradycardia, highlighting the need for careful monitoring, while dexamethasone has been shown to effectively reduce postoperative nausea and vomiting, making it a valuable adjunct in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Analgesia, Current Concepts, and Acute Pain Considerations. Helander, EM., Menard, BL., Harmon, CM., et al.[2022]

Opioid-induced respiratory depression is a major risk associated with opioid use, primarily mediated by μ receptors in the central nervous system, which can lead to life-threatening conditions like cardiorespiratory arrest.

While opioids can cause histamine release, leading to hemodynamic changes, serious allergic reactions are rare, and the FDA has warned about the risk of serotonin syndrome when opioids are used with other serotonergic medications, highlighting the need for caution in prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicities of opioid analgesics: respiratory depression, histamine release, hemodynamic changes, hypersensitivity, serotonin toxicity. Baldo, BA.[2022]

In a study of 303 patients undergoing ventral hernia repair, the addition of methocarbamol to pain management led to a significant reduction in the amount of opioids prescribed at discharge, decreasing from 75 MME to 60 MME.

Despite the lower opioid prescriptions, there was no increase in the need for opioid refills, suggesting that methocarbamol effectively manages pain without increasing reliance on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of methocarbamol on opioid use after ventral incisional hernia repair. Desai, S., Carbonell, C., Hoffman, K., et al.[2023]

The review emphasizes that while analgesics, both non-opioid (like paracetamol and NSAIDs) and opioid medications, are commonly used for pain management, they carry significant risks of adverse drug reactions (ADRs) that can often be prevented.

Recognizing and understanding the safety issues associated with analgesics is crucial for healthcare professionals to ensure effective pain treatment while minimizing risks, highlighting the importance of careful patient monitoring and consideration of individual medical factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues of current analgesics: an update. Cazacu, I., Mogosan, C., Loghin, F.[2022]

Oliceridine, a biased opioid agonist approved by the FDA, provides effective pain relief for moderate to severe acute pain, showing superior analgesia compared to placebo and equianalgesic effects to morphine without increasing respiratory complications, based on two Phase III trials involving patients after bunionectomy and abdominoplasty.

While initial studies suggest that Oliceridine may have a lower risk of opioid-induced respiratory depression and gastrointestinal issues compared to traditional opioids like morphine, further prospective studies are necessary to confirm its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oliceridine: A Novel Drug for the Management of Moderate to Severe Acute Pain - A Review of Current Evidence. Tan, HS., Habib, AS.[2021]

In the HOPE Hernia-1 study involving patients undergoing herniorrhaphy, the combination of HTX-011 (extended-release bupivacaine/low-dose meloxicam) with ibuprofen and acetaminophen resulted in 89.1% to 93.6% of patients not requiring opioid prescriptions post-surgery, indicating effective pain management without opioids.

The treatment regimen was well tolerated, with 95% of patients experiencing an opioid-free recovery and high satisfaction rates, suggesting that HTX-011 can significantly reduce opioid use while maintaining patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study. Minkowitz, H., Soto, R., Fanikos, J., et al.[2023]

Citations

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